BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3121807 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07960
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0107926V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0107926V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0417769V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE IMPEDANCES GREATER THAN 2,000 OHMS FOR ALL UNIPOLAR PAIRS AND BIPOLAR PAIRS ON BOTH DEVICES. THE REPORTER DID NOT HAVE SPECIFIC INFORMATION AT THE TIME OF WHICH ELECTRODES WERE OUT OF RANGE. THEY ATTEMPTED TO INCREASE DEFAULT SETTINGS BUT IT DID NOT RESOLVE THE ISSUE. IT WAS NOTED THE PATIENT WAS RECEIVING ¿ZERO THERAPEUTIC BENEFIT.¿ IT WAS ALSO NOTED THE PATIENT HAD FALLEN MULTIPLE TIMES. IT WAS FURTHER REPORTED THAT NO LEAD FRACTURES WERE SEEN IN THE X-RAY. IT WAS NOTED THAT THE ISSUE WAS NOT RESOLVED AND THAT THE PATIENT¿S OUTCOME HAD NOT CHANGED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BOTH IMPLANTABLE PULSE GENERATORS REPLACED AND WAS DOING WONDERFUL. THE LEADS OR EXTENSIONS WERE NOT TOUCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224420 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention